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Hodgkin LymphomaPhase 3H11NCT01652261

Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)

A Phase 3 study testing ABVD + FDG-PET/CT Scan treatment adaptation and BEACOPPesc in people with Hodgkin Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Denmark.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
ABVD + FDG-PET/CT Scan treatment adaptation and BEACOPPesc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteDenmark
Study dates
May 2013to Oct 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Previously untreated, histologically proven classical Hodgkin lymphoma
  • Clinical stages III/IV (Ann Arbor)
  • Age 18-60
  • WHO performance 0-2
  • Adequate organ function
  • Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.
  • Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations

Who cannot join

  • Pregnancy or lactation
  • Specific contraindications to BEACOPPesc therapy, including:
  • Poorly controlled diabetes mellitus
  • HIV infection,
  • Chronic active hepatitis B and/or hepatitis C
  • Concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group

The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.

Being tested
ABVD + FDG-PET/CT Scan treatment adaptation, BEACOPPesc
Keywords
advanced stage
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABVD + FDG-PET/CT Scan treatment adaptationDrug

  • BEACOPPescDrug

Study groups in NCT01652261
Study groupRoleWhat they receive
experimental armExperimentalAn experimental arm (early FDG-PET/CT-response adapted), where all patients are initially treated with a single cycle of ABVD. Very early FDG-PET/CT-negative patients continue on ABVD therapy to a total of six cycles. Very early FDG-PET/CT-positive patients receive 3 cycles of BEACOPPesc followed by another 3 cycles of BEACOPPesc. Mid-treatment evaluation is performed after 4 cycles. In case of treatment failure (less than partial remission (PR)), the patient goes off protocol treatment. Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).
Receives: Drug: ABVD + FDG-PET/CT Scan treatment adaptation; Drug: BEACOPPesc
standard armActive comparatorA standard arm, where patients are treated with four cycles of BEACOPPesc followed by 2 cycles of BEACOPPesc. FDG-PET/CT is performed after one cycle, but with no therapeutic consequences. Mid-treatment evaluation is performed after four cycles. In case of treatment failure (less than PR), the patient goes off protocol treatment. Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).
Receives: Drug: BEACOPPesc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from treatment failure

    Measured: 9 years after first patient in (FPI)

Secondary outcomes (5)

  1. response at the end of therapy

    Measured: 9 years after FPI

  2. Progression-free survival

    Measured: 9 years after FPI

  3. Overall survival

    Measured: 9 years after FPI

  4. Acute toxicity

    • Hematological toxicity (blood cell count) can be significant especially for patients who will receive BEACOPPesc .
    • Bleomycine interstitial pneumonitis has been frequently reported and requires the immediate stop of further bleomycine administration.
    • Rarely, procarbazine allergy and intolerance has been reported.
    • Nausea \& vomiting due to cyclophosphamide, doxorubicin, dacarbazine and procarbazine may be significant.
    • Total reversible alopecia occurs in most cases.
    • Escalated BEACOPP-related toxic deaths have been reported but do not exceed those observed with standard ABVD.

    Measured: 9 years after FPI

  5. Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events

    Measured: 9 years after FPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

Why it stopped: Study closed due to lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01652261
Sponsor's protocol ID
EORTC-20101-23101
Other IDs
2011-005473-22
Acronym
H11
Status last verified
Jun 2014
First submitted
18 Jul 2012
Last updated
15 Feb 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.

    PubMed 40135712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABVD + FDG-PET/CT Scan treatment adaptation and BEACOPPesc in people with Hodgkin Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from treatment failure (time frame: 9 years after first patient in (FPI)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01652261, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.

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